PharyngitisPhase 2NCT01919996

PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients

A Phase 2 study testing Azithromycin in people with Pharyngitis and Tonsillitis, run by Pfizer at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Pharyngitis, Tonsillitis
What is being tested?: Azithromycin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 6 sitesUnited States
Study dates: Dec 2013to Nov 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female patient, aged 12 to 17 years.
Requires outpatient treatment for acute pharyngitis/tonsillitis infection.
Appropriate to treat with oral azithromycin as an alternative to intramuscular penicillin, in the opinion of the investigator.
Positive rapid antigen detection test.

Who cannot join

History of clinically significant eye disorder that would interfere with protocol test procedures.
Hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide antibiotic.
Increased risk of QT prolongation.
Pregnant or breastfeeding.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Outpatient Center in Lincoln Park
Chicago, Illinois, 60614
Infant Welfare Society of Chicago
Chicago, Illinois, 60647
Murray Pediatrics
Murray, Utah, 84107
Martel Eye Medical Group
Rancho Cordova, California, 95670
Daynes Eye and Lasik
Salt Lake City, Utah, 84124

Other trials in United States

About this study

Official title: Ocular Effects Of Azithromycin Oral Solution In Pediatric Patients With Pharyngitis/Tonsillitis

This Post-Authorization Safety Study (PASS) is intended to fulfill a regulatory post-marketing requirement to provide data regarding visual abilities in children taking azithromycin (immediate-release formulation) for acute pharyngitis/tonsillitis. The primary objective of the study is to examine the incidence of clinically significant worsening in any of the following ophthalmic exams: best corrected visual acuity (distance), color vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination, in a group of approximately 30 pediatric patients taking azithromycin oral solution for treatment of an authorized indication of use (pharyngitis/ tonsillitis).

Read the detailed description

Study was terminated prematurely on October 16, 2015 following FDA decision to release Sponsor from post-marketing commitment. No safety and/or efficacy concerns identified.

Conditions: Pharyngitis, Tonsillitis
Being tested: Azithromycin
Keywords: Ocular safety, azithromycin, pharyngitis, tonsillitis
Medical subject headings: Pharyngitis, Tonsillitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AzithromycinDrug
Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days

Study groups in NCT01919996
Study group	Role	What they receive
Azithromycin	Experimental	Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days Receives: Drug: Azithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations
Clinically significant worsening is an observed worsening in any of the five ophthalmic exams: 1) Clinically significant worsening in best corrected visual activity (BCVA) (distance) at the final visit, in either eye, is defined as a decrease in score of 5 or more letters from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA. 2) An assessment of abnormal clinically significant at final visit in color vision Farnsworth Munsell 100 Hue Test (FM-100) in either eye. 3) An assessment of abnormal clinically significant at final visit in Amsler Grid in either eye. 4) Assessments of abnormal clinically significant at final visit in anterior segment biomicroscopy, in any of the 10 eye structures in either eye. 5) Assessments of abnormal clinically significant at final visit in dilated indirect ophthalmoscopy in any of the 5 eye structures in either eye.
Measured: 14 days

Secondary outcomes (2)

Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations
1 or more of these conditions are clinically significant improvement based on five ophthalmic exams:1) clinically significant improvement in BCVA(distance) at the final visit, in either eye, defined as an increase in score of 5 or more letters from baseline in ETDRS BCVA.2) Assessment of abnormal clinically significant at baseline and normal or abnormal, non-clinically significant at final visit in color vision(FM-100) in either eye. 3) Assessment of abnormal clinically significant at baseline and normal/abnormal, non-clinically significant at final visit in Amsler Grid in either eye. 4) Assessments of abnormal clinically significant at baseline and normal/abnormal, non-clinically significant at final visit in anterior segment biomicroscopy, in any of the 10 eye structures in either eye. 5)Assessments of abnormal clinically significant at baseline and normal/abnormal, nonclinically significant at final visit in dilated ophthalmoscopy in any of the 5 eye structures in either eye.
Measured: 14 days
Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations
Clinically significant change (improvement or worsening) is based on five ophthalmic exams at baseline and the final visit. Any 1 or more of these conditions are a clinically significant change: 1) A worsening in BCVA (distance), as defined in outcome measure 1 OR an improvement in BCVA (distance) as defined in outcome measure 2. 2) A worsening in color vision (FM-100), as defined in outcome measure 1 OR an improvement in color vision (FM-100) as defined in outcome measure 2. 3) A worsening in Amsler Grid, as defined in outcome measure 1, OR an improvement in Amsler Grid, as defined in outcome measure 2. 4) A worsening in anterior segment biomicroscopy, as defined in outcome measure 1 OR an improvement in anterior segment biomicroscopy as defined in outcome measure 2. 5) A worsening in dilated indirect ophthalmoscopy, as defined in outcome measure 1 OR an improvement in dilated indirect ophthalmoscopy as defined in outcome measure 2.
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Nov 2015

First posted9 Aug 2013 (estimated)
Study startDec 2013
Primary completionOct 2015
Study completionNov 2015

Why it stopped: See Termination Statement in the Detailed Description below

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PharyngitisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01919996
Sponsor's protocol ID: A0661206
Other IDs: 208291, 2016-001119-19, 2016
Status last verified: Jul 2016
First submitted: 7 Aug 2013
Last updated: 5 Aug 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ocular Effects Of Azithromycin Oral Solution In Pediatric Patients With Pharyngitis/Tonsillitis
ClinicalTrials.gov ID: NCT01919996
Acronym / sponsor ID: A0661206
Conditions: Pharyngitis, Tonsillitis
Keywords: Ocular safety, azithromycin, pharyngitis, tonsillitis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: See Termination Statement in the Detailed Description below
Enrolment: 8 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: Oct 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 9 Aug 2013 (estimated)
Results: Posted 6 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study was terminated prematurely on October 16, 2015 following FDA decision to release Sponsor from post-marketing commitment. No safety and/or efficacy concerns identified.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Azithromycin	Experimental	Drug: AzithromycinAzithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Male or female patient, aged 12 to 17 years.
Requires outpatient treatment for acute pharyngitis/tonsillitis infection.
Appropriate to treat with oral azithromycin as an alternative to intramuscular penicillin, in the opinion of the investigator.
Positive rapid antigen detection test.

Key exclusion criteria (4 listed)

History of clinically significant eye disorder that would interfere with protocol test procedures.
Hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide antibiotic.
Increased risk of QT prolongation.
Pregnant or breastfeeding.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AzithromycinAzithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days	Drug	Azithromycin

Primary outcome

Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations
Time frame: 14 days
Clinically significant worsening is an observed worsening in any of the five ophthalmic exams: 1) Clinically significant worsening in best corrected visual activity (BCVA) (distance) at the final visit, in either eye, is defined as a decrease in score of 5 or more letters from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA. 2) An assessment of abnormal clinically significant at final visit in color vision Farnsworth Munsell 100 Hue Test (FM-100) in either eye. 3) An assessment of abnormal clinically significant at final visit in Amsler Grid in either eye. 4) Assessments of abnormal clinically significant at final visit in anterior segment biomicroscopy, in any of the 10 eye structures in either eye. 5) Assessments of abnormal clinically significant at final visit in dilated indirect ophthalmoscopy in any of the 5 eye structures in either eye.

2 secondary outcomes

Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations
Time frame: 14 days
Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations
Time frame: 14 days

Results and safety

Results posted to the registry on 6 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Azithromycin	8	8

Primary outcome: Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations

Time frame: 14 days. Number. Unit: percentage of participants

Measure	Azithromycin n = 8
Clinically significant worsening - Yes	0.0
Clinically significant worsening - No	87.5
Not Evaluable	12.5

Population analysed: The safety population included all enrolled participants that took at least one dose of study medication. One participant was not evaluable because visual acuity was not corrected at Baseline (Day 1) and was corrected at Final Visit (Day 14).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to 28 calendar days after the last administration of the study medication (up to 40 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Azithromycin	0 of 8 (0%)	0 of 8 (0%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated after the FDA released the Sponsor from the PMC. The FDA deemed the study as impracticable, given the azithromycin dose studied in the PMC was not used and the available data did not identify a signal for ocular toxicity.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Azithromycin in people with Pharyngitis and Tonsillitis, run by Pfizer at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01919996.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016.